Delivery of therapeutic and marking substance through intra lumen expansion of a delivery device

Abstract

A balloon catheter is formed with a plurality of depressions. The balloon is coated with a matrix incorporating a therapeutic substance, which additionally fills the depressions. When the balloon is expanded within a body lumen, the therapeutic substance may diffuse into the lumen wall, or all or a portion of the coating transfers to the lumen wall. A lattice frame may surround the balloon, applied prior to coating if the coating is to transfer, operative to maintain a more linear balloon profile during inflation, promoting more even transfer pressure. A contrast dye is incorporated into the transferred coating, enabling ready location and inspection of the treated lumen area. Projections may alternately be formed in the balloon surface, operative to urge the coating and therapeutic substance between cells, or past cell layers of the lumen, to the interior of the lumen wall. Prior to transfer, an extended inflation period, possibly including the use of perfusion ports to maintain blood supply, enables a larger initial quantity of therapeutic substance to diffuse into the body lumen, prior to transfer of the coating and withdrawal of the catheter, balloon, and frame.

Description

FIELD OF THE INVENTION[0001]The present invention relates to balloon catheters for distal drug delivery within the body, wherein the balloon catheter applies a therapeutic substance to the interior surface of a body lumen upon inflation therein.BACKGROUND OF THE INVENTION[0002]The human body includes arterial and venous conduits which run throughout various sections of the human body. These conduits conduct blood into and from the heart which maintain the circulation that helps to sustain the metabolic events in the body. The vessels undergo biological, physiological, and mechanical changes depending on the body metabolism which determine the functionality of the wall of the artery.[0003]Sometimes the wall of an artery becomes occluded due to deposits of fatty tissues which in turn form plaque on the walls of the artery. These plaques then have to be removed to restore the normal function of the artery. One known mechanism of removing the plaque is to compress the plaque against the...

AI Technical Summary

Benefits of technology

[0018]Accordingly, a larger quantity of therapeutic substance may be delivered, without a requirement of infusion, and without leaving an implant within the body.

[0029]The wire frame described is additionally beneficial for promoting a uniform contact pressure for coatings containing substances which must diffuse or elute into the lumen while the balloon is expanded, as well. In this application, an even contact pressure increases the likelihood of consistent dosing throughout the region of desired application.

Problems solved by technology

In Klein, however, the application of a therapeutic substance only takes place while the balloon is inflated.

Thus, the period of treatment is thus necessarily short, and terminates once the surgical procedure is over, and the catheter is removed.

Thomas does not disclose the advantages of delivering a substance using a balloon catheter itself as the delivery device.

Where it is not necessary to leave an implant in the body, however, Thomas fails to provide a solution.

Again, however, delivery is effectively halted when the balloon is removed.

Images